Vanos

Dosage Form: cream
FULL PRESCRIBING INFORMATION

Indications and Usage for Vanos

Indication

Vanos (fluocinonide) Cream, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4)].

Limitation of Use

Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Vanos Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.

Vanos Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

Vanos Dosage and Administration

For topical use only. Vanos Cream is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of Vanos Cream once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of Vanos Cream once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14)].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Vanos Cream once or twice daily to the affected areas as directed by a physician.

Dosage Forms and Strengths

Cream, 0.1%.

Each gram of Vanos Cream contains 1 mg of fluocinonide in a white to off-white cream base.

Contraindications

None.

Warnings and Precautions

Effect on Endocrine System

Systemic absorption of topical corticosteroids, including Vanos Cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of Vanos Cream for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1)].

HPA axis suppression has been observed with Vanos Cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis and 4 out of 123 pediatric patients with atopic dermatitis [see Use in Specific Population (8.4) and Clinical Pharmacology (12.2)].

Because of the potential for systemic absorption, use of topical corticosteroids, including Vanos Cream, may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.

Studies conducted in pediatric patients demonstrated reversible HPA axis suppression after use of Vanos Cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Vanos Cream due to their larger skin surface-to-body-mass ratios [See Use in Specific Populations (8.4)].

Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasis, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and malaria. Some local adverse reactions may be irreversible.

Concomitant Skin Infections

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Vanos Cream should be discontinued until the infection has been adequately controlled.

Allergic Contact Dermatitis

If irritation develops, Vanos Cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

Adverse Reactions

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with Vanos Cream for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows:

Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials

Adverse Reaction	Vanos Cream, once daily (n=216)	Vanos Cream, twice daily (n=227)	Vehicle Cream, once or twice daily (n=211)
Headache	8 (3.7%)	9 (4.0%)	6 (2.8%)
Application Site Burning	5 (2.3%)	4 (1.8%)	14 (6.6%)
Nasopharyngitis	2 (0.9%)	3 (1.3%)	3 (1.4%)
Nasal Congestion	3 (1.4%)	1 (0.4%)	0

Safety in patients 12 to 17 years of age was similar to that observed in adults.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Vanos Cream:

Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain and condition aggravated.

Immune System Disorders: hypersensitivity.

Nervous System Disorders: headache and dizziness.

Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation and skin tightness.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Therefore, Vanos Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and efficacy of Vanos Cream in pediatric patients younger than 12 years of age have not been established; therefore use in pediatric patients younger than 12 years of age is not recommended.

HPA axis suppression was studied in 4 sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area, treated once daily or twice daily with Vanos Cream. The first cohort of 31 patients (mean 36.3% BSA) 12 to < 18 years old; the second cohort included 31 patients (mean 39.0% BSA) 6 to < 12 years old; the third cohort included 30 patients (mean 34.6% BSA) 2 to < 6 years old; the fourth cohort included 31 patients (mean 40.0% BSA) 3 months to < 2 years old. Vanos Cream caused HPA-axis suppression in 1 patient in the twice daily group in Cohort 1, 2 patients in the twice daily group in Cohort 2, and 1 patient in the twice daily group in Cohort 3. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis. Signs of skin atrophy were present at baseline and severity was not determined making it difficult to assess local skin safety. Therefore, the safety of Vanos Cream in patients younger than 12 years of age has not been demonstrated [see Warnings and Precautions (5.1)].

HPA axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA-axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to cosyntropin (ACTH1–24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Clinical studies of Vanos Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Overdosage

Topically applied Vanos Cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

Vanos Description

Vanos (fluocinonide) Cream, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58.

It has the following chemical structure:

Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol.

Each gram of Vanos Cream contains 1 mg micronized fluocinonide in a cream base of propylene glycol USP, dimethyl isosorbide, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate NF, purified water USP, carbopol 980 NF, diisopropanolamine, and anhydrous citric acid USP.

Vanos - Clinical Pharmacology

Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Vanos Cream in corticosteroid responsive dermatoses is unknown.

Pharmacodynamics

Vasoconstrictor studies performed with Vanos Cream in healthy subjects indicate that it is in the super-high range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.

Application of Vanos Cream twice daily for 14 days in 18 adult subjects with plaque-type psoriasis (10–50% BSA, mean 19.6% BSA) and 31 adult subjects (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2–10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 subjects with psoriasis (with 12% and 25% BSA) and 1 subject with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH1–24) [see Warnings and Precautions (5.1)].

HPA-axis suppression following application of Vanos Cream, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to < 18 years of age with atopic dermatitis (mean BSA range 34.6 % – 40.0 %). HPA-axis suppression was observed in 4 patients in the twice daily groups. Follow-up testing 14 days after treatment discontinuation demonstrated a normally responsive HPA axis in all 4 suppressed patients [see Warnings and Precautions (5.1) and Use in Specific populations (8.4)].

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of Vanos Cream because of severe immunosuppression induced in a 13-week dermal rat study. The effects of fluocinonide on fertility have not been evaluated.

Fluocinonide revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and chromosomal aberration assay using human lymphocytes). However, fluocinonide was positive for clastogenic potential when tested in the in vivo mouse micronucleus assay.

Topical (dermal) application of 0.0003%–0.03% fluocinonide cream to rats once daily for 13 weeks resulted in a toxicity profile generally associated with long term exposure to corticosteroids including decreased skin thickness, adrenal atrophy, and severe immunosuppression. A NOAEL could not be determined in this study. In addition, topical (dermal) application of 0.1% fluocinonide cream plus UVR exposure to hairless mice for 13 weeks and 150–900 mg/kg/day of 0.1% fluocinonide cream to minipigs (a model which more closely approximates human skin) for 13 weeks produced glucocorticoid-related suppression of the HPA axis, with some signs of immunosuppression noted in the dermal minipig study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.

Clinical Studies

Two adequate and well-controlled efficacy and safety studies of Vanos Cream have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with Vanos Cream for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2.

Table 2: Plaque-type Psoriasis in Adults

	Vanos Cream, once daily (n=107)	Vehicle, once daily (n=54)	Vanos Cream, twice daily (n=107)	Vehicle, twice daily (n=55)
* Cleared or almost cleared
Subjects cleared	0 (0)	0 (0)	6 (6%)	0 (0)
Subjects achieving treatment success*	19 (18%)	4 (7%)	33 (31%)	3 (5%)

Table 3: Atopic Dermatitis in Adults

	Vanos Cream, once daily (n=109)	Vehicle, once daily (n=50)	Vanos Cream, twice daily (n=102)	Vehicle, twice daily (n=52)
* Cleared or almost cleared
Subjects cleared	11 (10%)	0 (0)	17 (17%)	0 (0)
Subjects achieving treatment success*	64 (59%)	6 (12%)	58 (57%)	10 (19%)

No efficacy studies have been conducted to compare Vanos (fluocinonide) Cream, 0.1% with any other topical corticosteroid product, including fluocinonide cream 0.05%.

How Supplied/Storage and Handling

Vanos Cream is white to off-white in color and is supplied in tubes as follows:

 

30 g (NDC 99207-525-30)

 

60 g (NDC 99207-525-60)

 

120 g (NDC 99207-525-10)

Store at controlled room temperature: 15° to 30°C (59° to 86°F).

Keep the tube tightly closed.

Patient Counseling Information

[See FDA-approved patient labeling (Patient Information)]

Patients using Vanos Cream should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects:

• Vanos Cream is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. It should not be used on the face, groin, and underarms.


• Vanos Cream should not be used for any disorder other than that for which it was prescribed.


• The treated skin area should not be bandaged or otherwise covered or wrapped, so as to be occlusive unless directed by the physician.


• Patients should report to their physician any signs of local adverse reactions.


• Other corticosteroid-containing products should not be used with Vanos Cream without first talking to the physician.


• As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen in 2 weeks, the patient should be instructed to contact a physician. The safety of the use of Vanos Cream for longer than 2 weeks has not been established.


• Patients should be informed to not use more than 60 g per week of Vanos Cream. Do not use more than half of the 120 g tube per week.


• Patients should inform their physicians that they are using Vanos Cream if surgery is contemplated.


• Patients should wash their hands after applying medication.

PATIENT INFORMATION

Vanos® (VAN-ōs) (fluocinonide)

Cream 0.1%

Important: For skin use only. Do not get Vanos Cream in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

Read the Patient Information that comes with Vanos Cream before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your condition or treatment.

What is Vanos Cream?

Vanos Cream is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.

• You should not use Vanos Cream for longer than 2 weeks in a row.


• You should not use more than 60 grams of Vanos Cream or more than half of the 120 gram tube in 1 week.


• Vanos Cream should not be used:
  
  • if you have skin swelling or redness on the nose of face (rosacea)
  
  
  • for a scaly or bumpy rash around your mouth (perioral dermatitis)
  
  
  • on your face, underarms, or groin area
  
  

It is not known if Vanos Cream is safe and effective in children under 12 years of age.

What should I tell my doctor before using Vanos Cream?

Before using Vanos Cream, tell your doctor if you:

• have had irritation or other skin reaction to a steroid medicine in the past


• adrenal gland problems


• plan to have surgery


• are pregnant or plan to become pregnant. It is not known if Vanos Cream will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.


• are breast-feeding or plan to breastfeed. It is not known if Vanos Cream passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Vanos Cream.

Tell your doctor about all the medicine you take including prescriptions and non-prescriptions medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a corticosteroid medicine by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How should I use Vanos Cream?

• See "What is Vanos Cream?"


• Use Vanos Cream exactly as your doctor tells you.


• This medicine is for use on the skin only. Do not use Vanos Cream in your eyes, mouth or vagina.


• Wash your hands after you use Vanos Cream.


• Do not use Vanos Cream for longer than 2weeks in a row.


• Talk to your doctor if your skin does not get better after 2 weeks of treatment with Vanos Cream.


• Do not bandage or cover the skin treated with Vanos Cream unless your doctor tells you to.

What are the possible side effects with Vanos Cream?

Vanos may cause side effects, including:

• Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency while you are using Vanos Cream. Tell your doctor if you have any of these symptoms of adrenal insufficiency:
  
  • tiredness that worsens and does not go away
  
  
  • nausea or vomiting
  
  
  • dizziness or fainting
  
  
  • muscle weakness
  
  
  • irritability and depression
  
  
  • loss of appetite
  
  
  • weight loss
  
  


• Cushing's syndrome, when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. Symptoms can include:
  
  • weight gain, especially around your upper back and midsection
  
  
  • slow healing of cuts, insect bites and infections
  
  
  • tiredness and muscle weakness
  
  
  • depression, anxiety and irritability
  
  
  • roundness of your face (moon face)
  
  
  • new or worsening high blood pressure
  
  

The most common side effect of Vanos Cream is burning of your skin treated with Vanos Cream.

Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with Vanos Cream. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Medicis at 1-800-900-6389.

How should I store Vanos Cream?

• Store Vanos Cream at room temperature, between 59°F to 86°F (15°C to 30°C).


• Keep the tube tightly closed.

Keep Vanos Cream and all medicines out of the reach of children.

General information about Vanos Cream

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Vanos Cream for a condition for which it was not prescribed. Do not give Vanos Cream to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Vanos Cream. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Vanos Cream that is written for healthcare professionals.

What are the ingredients in Vanos Cream?

Active ingredient: fluocinonide 0.1%

Inactive ingredients: propylene glycol, dimethyl isosorbide, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbopol 980, diisopropanolamine, and anhydrous citric acid.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Medicis, The Dermatology Company

Scottsdale, AZ 85256

Manufactured by:

Contract Pharmaceuticals Ltd.

Mississauga, Ontario

Canada L5N 6L6

Product of Italy

U.S. Patents 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and Patents Pending

Vanos is a registered trademark of Medicis Pharmaceutical Corporation.

Approved 11/2011

05100242

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Vanos®

(fluocinonide) cream 0.1%

NDC 99207-525-30

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC, ORAL,

OR INTRAVAGINAL USE

Rx only

30 g

MEDICIS

The Dermatology Company®

Vanos  fluocinonide  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-525 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fluocinonide (fluocinonide) fluocinonide 1 mg  in 1 g

Inactive Ingredients Ingredient Name Strength propylene glycol   dimethyl isosorbide   PEG-100 stearate   glyceryl monostearate   water   carbomer homopolymer type c   diisopropanolamine   anhydrous citric acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-525-02 20 TUBE In 1 CARTON contains a TUBE 1 1.5 g In 1 TUBE This package is contained within the CARTON (99207-525-02) 2 99207-525-30 1 TUBE In 1 CARTON contains a TUBE 2 30 g In 1 TUBE This package is contained within the CARTON (99207-525-30) 3 99207-525-60 1 TUBE In 1 CARTON contains a TUBE 3 60 g In 1 TUBE This package is contained within the CARTON (99207-525-60) 4 99207-525-10 1 TUBE In 1 CARTON contains a TUBE 4 120 g In 1 TUBE This package is contained within the CARTON (99207-525-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021758	03/13/2006

Labeler - Medicis Pharmaceutical Corp (182837492)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmaceutical Limited (CPL)		248761249	MANUFACTURE

Revised: 12/2011Medicis Pharmaceutical Corp

AcipHex

Generic Name: Rabeprazole Sodium
Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]-benzimidazole sodium
Molecular Formula: C₁₈H₂₀N₃NaO₃S
CAS Number: 117976-90-6

Special Alerts:

[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.^{1 2 3 4 5 6}

Uses for AcipHex

Gastroesophageal Reflux (GERD)

Short-term treatment of symptomatic GERD (e.g., heartburn) in patients without erosive esophagitis.¹

Short-term treatment of erosive esophagitis in patients with GERD.^{1 2 3 15 18}

Maintain healing and decrease recurrence of erosive esophagitis.^{1 2 3}

Duodenal Ulcer

Short-term treatment of active duodenal ulcer.^{1 2 3 17}

Treatment of Helicobacter pylori infection and duodenal ulcer disease.¹ Used in conjunction with amoxicillin and clarithromycin (triple therapy).¹

Crohn's Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn's disease†, including esophageal†, gastroduodenal†, and jejunoileal† disease.^{27 28 29 31 32 33}

Pathologic GI Hypersecretory Conditions

Long-term treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome).^{1 3}

AcipHex Dosage and Administration

Administration

Oral Administration

Administer orally; may give without regard to meals, but manufacturer recommends administration after morning meal in patients with duodenal ulcer.¹

When used in combination with clarithromycin and amoxicillin for treatment of H. pylori infection and duodenal ulcer disease, take all 3 drugs twice daily with morning and evening meals.¹

Swallow tablets intact; do not chew, crush, or split.¹

Antacids may be used concomitantly as needed for pain relief.^{1 19}

Dosage

Available as rabeprazole sodium; dosage expressed in terms of the salt.¹

Adults

GERD

GERD without Erosive Esophagitis

Oral

20 mg once daily for 4 weeks; may give additional 4 weeks if symptoms are not completely resolved.¹

Treatment of Erosive Esophagitis

Oral

20 mg once daily^{1 2 15 18} for 4–8 weeks.^{1 15} If not healed after 8 weeks, consider additional 8 weeks of therapy (up to 16 weeks for a single course).¹

Maintenance of Healing of Erosive Esophagitis

Oral

20 mg once daily.^{1 2 15 18} Chronic, lifelong therapy may be appropriate.²⁶

Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

20 mg once daily for up to 4 weeks;^{1 2 17 18} some patients may require additional therapy.¹

Helicobacter pylori Infection and Duodenal Ulcer Disease

Oral

Triple therapy: 20 mg twice daily for 7 days in conjunction with amoxicillin and clarithromycin.¹

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)

Oral

60 mg once daily.¹ Dosages up to 100 mg once daily or 60 mg twice daily have been used.¹ Divided doses may be required.¹ Adjust dosage as needed, continue treatment as long as necessary.¹ Has been used continuously for up to 1 year.¹

Cautions for AcipHex

Contraindications

• 
  

  Known hypersensitivity to rabeprazole, any ingredient in the formulation, or other substituted benzimidazoles (e.g., esomeprazole, lansoprazole, pantoprazole, omeprazole).¹

  
  

Warnings/Precautions

General Precautions

GI Effects

Response to rabeprazole does not preclude presence of occult gastric neoplasm.¹

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).^{35 36}

Hip Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.^{39 300 301 302 303 304 305 309} Magnitude of risk is unclear;^{39 300 301 302 303 304 305 310} causality not established.³⁰⁵ FDA is continuing to evaluate this safety concern.³⁰⁵

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.^{39 301 303 305 307 309}

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients' bone health according to current standards of care.^{39 303 305 307 309}

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether rabeprazole is distributed into milk; discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 23}

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Hepatic Impairment

Use with caution in patients with severe impairment.^{1 21}

Common Adverse Effects

Headache.¹

Interactions for AcipHex

Metabolized in the liver, principally by CYP3A and 2C19 isoenzymes.^{1 7 8 9}

Drugs Metabolized by Cytochrome P-450 Enzymes

No clinically important interactions with some drugs that are metabolized by CYP isoenzymes under single dose conditions; effects of rabeprazole have not been studied under steady-state conditions.¹

Specific Drugs

Drug	Interaction	Comments
Amoxicillin	Increased rabeprazole and 14-hydroxyclarithromycin AUC and plasma concentrations when administered with amoxicillin and clarithromycin1	Not expected to result in toxicity1
Antacids	No clinically important effects on rabeprazole pharmacokinetics1
Atazanavir	Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response40 42	Manufacturer of rabeprazole states that concomitant administration with atazanavir is not recommended40 Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir41 42 For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)41 42 Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended41 42
Clarithromycin	Increased rabeprazole and 14-hydroxyclarithromycin AUC and plasma concentrations when administered with amoxicillin and clarithromycin1	Not expected to result in toxicity1
Clopidogrel	Certain CYP2C19 inhibitors (e.g., omeprazole) can reduce exposure to clopidogrel's active metabolite and decrease platelet inhibitory effect;223 224 225 228 232 233 236 potentially may reduce clopidogrel's clinical efficacy;219 220 221 224 229 230 234 235 236 237 238 240 311 Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown219 220 221 224 232	Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients237 240 243 248 250 American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs; H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311
Cyclosporine	Rabeprazole inhibited cyclosporine metabolism in vitro1
Diazepam	No pharmacokinetic interaction observed after single doses1
Gastric pH-dependent drugs (e.g., digoxin, ketoconazole)	Rabeprazole may decrease drug absorption1	Monitor if used concomitantly1
Phenytoin	No pharmacokinetic interaction observed after single doses1
Sucralfate	Possible delayed proton-pump inhibitor absorption and decreased bioavailability 34	Administer proton-pump inhibitor at least 30 minutes before sucralfate34
Theophylline	No pharmacokinetic interaction observed after single doses1
Warfarin	Potential for increased INR and PT1	Monitor PT and INR1

AcipHex Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability with 20 mg dose is about 52%.¹ Repeated dosing does not affect pharmacokinetics.¹

Onset

Within 1 hour.^{1 23} Median inhibition of 24-hour gastric acidity is 88% of maximum after first dose.¹

Food

High-fat meal may delay absorption but does not affect extent.^{1 20 23}

Special Populations

AUC increased 50–60% in Japanese males receiving a different rabeprazole formulation.¹

AUC doubled in patients with mild to moderate compensated cirrhosis.¹ Peak plasma concentrations and AUCs increased 20% in patients with mild to moderate hepatic impairment.¹

In geriatric patients, peak plasma concentration increased by 60% and AUCs doubled.¹

Distribution

Extent

Not known whether rabeprazole crosses the placenta or is distributed into milk.¹

Prolonged binding to gastric parietal proton pump enzyme.^{1 3}

Plasma Protein Binding

Approximately 96%.¹

Elimination

Metabolism

Metabolized in the liver, principally by CYP3A and CYP2C19.^{1 7 8 9} Principal thioether and sulphone metabolites found in plasma are inactive.¹

Elimination Route

Excreted as metabolites in urine (90%); remainder in feces.¹

Half-life

1–2 hours.¹

Special Populations

In patients with mild to moderate compensated cirrhosis, elimination half-life was 2–3 times greater, and clearance decreased to less than one-half.¹

In patients with poor CYP2C19 metabolizer phenotype, metabolism is slower than in those with extensive (or rapid) metabolizer phenotype.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Actions

• 
  

  Inhibits basal and stimulated gastric acid secretion.¹

  
  


• 
  

  Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that binds to and inactivates hydrogen-potassium ATPase (proton- or acid-pump), blocking final step in secretion of hydrochloric acid.^{1 2 3 4 5 6} Sustained inactivation of hydrogen-potassium ATPase results in prolonged duration of action.^{1 3}

  
  


• 
  

  Suppresses gastric H. pylori in patients with duodenal ulcer and/or reflux esophagitis infected with the organism.^{2 3 10 11} Combined therapy with rabeprazole and one or more appropriate anti-infectives (e.g., amoxicillin, clarithromycin) can effectively eradicate H. pylori gastric infection.^{2 3 10 11}

  
  

Advice to Patients

• 
  

  Importance of swallowing tablets whole, without crushing or chewing.¹

  
  


• 
  

  Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.^{305 309}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{1 23} Antacids may be used concomitantly as needed for pain relief.^{1 19}

  
  


• 
  

  Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Rabeprazole Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, delayed-release (enteric-coated)	20 mg	AcipHex	Eisai (also promoted by Ortho-McNeil-Janssen)

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Aciphex 20MG Enteric-coated Tablets (EISAI): 30/$233.99 or 90/$660.00

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 24, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Eisai Inc. and Janssen Pharmaceutica Inc. AcipHex (rabeprazole sodium) delayed-release tablets prescribing information. Teaneck and Titusville, NJ; 2003 Aug.

2. Prakash A, Faulds D. Rabeprazole. Drugs. 1998; 55:261-7. [PubMed 9506245]

3. Richardson P, Hawkey CJ, Stack WA. Proton pump inhibitors. Pharmacology and rationale for use in gastrointestinal disorders. Drugs. 1998; 56:307-35. [PubMed 9777309]

4. Morii M, Hamatani K, Takeguchi N. The proton pump inhibitor, E3810, binds to the N-terminal half of the α-subunit og gastric H+,K(+)-ATPase. Biochem Pharmacol. 1995; 16:1729-34.

5. Williams MP, Sercombe J, Hamilton MI et al. A placebo-controlled trial to assess the effects of 8 days of dosing with rabeprazole versus omeprazole on 24-h intragastric acidity and plasma gastrin concentrations in young healthy male subjects. Aliment Pharmacol Ther. 1998; 12:1079-89. [PubMed 9845397]

6. Lew EA, Barbuti RC, Kovacs TO et al. An ascending single-dose safety and tolerance study of an oral formulation of rabeprazole (E3810). Aliment Pharmacol Ther. 1998; 12:667-72. [PubMed 9701531]

7. VandenBranden M, Ring BJ, Binkley SN et al. Interaction of human liver cytochromes P450 in vitro with LY307640, a gastric proton pump inhibitor. Pharmacogenetics. 1996; 6:81-91. [PubMed 8845864]

8. Yasuda S, Horai Y, Tomono Y et al. Comparison of the kinetic disposition and metabolism of E3810, a new proton inhibitor, and omeprazole in relation to S-mephenytoin 4′-hydroxylation status. Clin Pharmacol Ther. 1995; 58:143-54. [IDIS 352453] [PubMed 7648764]

9. Ishizaki T, Chiba K, Manabe K et al. Comparison of the interaction potential of a new proton pump inhibitor, E3810, versus omeprazole with diazepam in extensive and poor metabolizers of S-mephenytoin 4′-hydroxylation. Clin Pharmacol Ther. 1995; 58:155-64. [IDIS 352454] [PubMed 7648765]

10. Miwa H, Ohkura R, Murai T et al. Impact of rabeprazole, a new proton pump inhibitor, in triple therapy for Helicobacter pylori infection-comparison with omeprazole and lansoprazole. Aliment Pharmacol Ther. 1999; 13:741-6. [PubMed 10383502]

11. Stack WA, Knifton A, Thirwell D et al. Safety and efficacy of rabeprazole in combination with four antibiotic regimens for eradication of Helicobacter pylori in patients with chronic gastritis with or without peptic ulceration. Am J Gastroenterol. 1998; 93:1909-13. [IDIS 414937] [PubMed 9772054]

12. Tsuchiya M, Imamura L, Park JB et al. Helicobacter pylori urease inhibition by rabeprazole, a proton pump inhibitor. Biol Pharm Bull. 1995; 18:1053-6. [PubMed 8535394]

13. Park JB, Imamura L, Kobashi K. Kinetic studies of Helicobacter pylori urease inhibition by a novel proton pump inhibitor, rabeprazole. Biol Pharm Bull. 1996; 19:182-7. [PubMed 8850302]

14. Hirai M, Azuma T, Ito S et al. A proton pump inhibitor, E3810, has antibacterial activity through niding to Helicobacter pylori. J Gastroenterol. 1995; 30:461-4. [PubMed 7550855]

15. Dekkers CP, Beker JA, Thjodleifsson B et al for the European Rabeprazole Study Group. Double-blind comparison (correction of double-blind, placebo-controlled comparison) of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1999; 13:49-57. [PubMed 9892879]

16. National Institutes of Health Consensus Development Group. Gastroesophageal reflux disease (hiatal hernia and heartburn). NIH Publication No. 94-882; 1994 Sep.

17. Dekkers CP, Beker JA, Thjodleifsson B et al. Comparison of rabeprazole 20 mg versus omperazole 20 mg in the treatment of active duodenal ulcer: a European multicentre study. Aliment Pharmacol Ther. 1999; 13:179-86. [PubMed 10102948]

18. Cloud ML, Enas N, Humphries TJ et al for the Rabeprazole Study Group. Rabeprazole in treatment of acid peptic diseases: results of three placebo-controlled dose-response clinical trials in duodenal ulcer, gastric ulcer, and gastroesophageal reflux disease (GERD). Dig Dis Sci. 1998; 43:993-1000. [IDIS 406275] [PubMed 9590413]

19. Yasuda S, Higashi S, Murakami M et al. Antacids have no influence on the pharmacokinetics of rabeprazole, a new proton pump inhibitor, in healthy volunteers. Int J Clin Pharmacol Ther. 1999; 37:249-53. [IDIS 428678] [PubMed 10363624]

20. Yasuda S, Ohnishi A, Ogawa T et al. Pharmacokinetic properties of E3810, a new proton pump inhibitor, in healthy male volunteers. Int J Clin Pharmacol Ther. 1994; 32:466-73. [PubMed 7820329]

21. Hoyumpa AM, Trevino-Alanis H, Grimes I et al. Rabeprazole: pharmacokinetics in patients with stable, compensated cirrhosis. Clin Ther. 1999; 21:691-701. [IDIS 428164] [PubMed 10363734]

22. Keane WF, Swan SK, Grimes I et al. Rabeprazole: pharmacokinetics and tolerability in patients with stable, end-stage renal failure. J Clin Pharmacol. 1999; 39:927-33. [IDIS 432022] [PubMed 10471983]

23. Eisai Inc. Teaneck, NJ: Personal communication.

24. Shinomura Y, Kanayama S, Miyazaki Y et al. A clinical study of the effects of E3810 (rabeprazole sodium) for the treatment of gastric and duodenal ulcers: a comparison of post-breakfast and bedtime dosing regimens. Mod Physician. 1994; 14:69-84.

25. Eisai Ltd. and Janssen-Cilag Pharmaceutica Inc. Pariet (rabeprazole sodium) gastro-resistant tablets product monograph. London, 1998 Sep. RabeprazoleRestricted Distribution/6

26. DeVault KR, Castell DO, Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 1999; 94:1434-42. [IDIS 429620] [PubMed 10364004]

27. Hanauer SB, Sandborn W, and the Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn's disease in adults: Practice Guidelines. Am J Gastroenterol. 2001; 96:635-43. [IDIS 461432] [PubMed 11280528]

28. Valori RM, Cockel R. Omeprazole for duodenal ulceration in Crohn's disease. Br Med J. 1990; 300:438-9.

29. Bianchi G, Ardizzone S, Petrillo M et al. Omeprazole for peptic ulcer in Crohn's disease. Am J Gastroenterol. 1991; 86: 245-6. [PubMed 1992643]

30. Przemioslo RT, Mee AS. Omeprazole in possible esophageal Crohn's disease. Dig Dis Sci. 1994; 39:1594-5. [IDIS 333053] [PubMed 8026276]

31. Dickinson JB. Is omeprazole helpful in inflammatory bowel disease? J Clin Gastroenterol. 1994; 18:317-9.

32. Abrahao LJ Jr., Abrahao LJ, Vargas C et al. [Gastoduodenal Crohn's disease—report of 4 cases and review of the literature]. (Portuguese; with English abstract.) Arq Gastroenterol. 2001; 38:57-62.

33. Freston JW. Review article: role of proton pump inhibitors in non-H. pylori-related ulcers. Aliment Pharmacol Ther. 20001; 15(Suppl 2):2-5.

34. TAP. Prevacid (lansoprazole) delayed-release capsules, for delayed-release oral suspension and delayed-release orally disintegrating tablets prescribing information. Lake Forest, IL; 2003 Aug.

35. Laheij RJF, Sturkenboom MCJM, Hassing RJ et al. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004; 292:1955-60. [IDIS 522989] [PubMed 15507580]

36. Gregor JC. Acid suppression and pneumonia.; a clinical indication for rational prescibing. JAMA. 2004;292:2012-3. Editorial.

37. AstraZeneca, Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2001 Aug.

38. TAP. Prevacid (lansoprazole) delayed-release capsules, for delayed-release oral suspension and delayed-release orally disintegrating tablets prescribing information. Lake Forest, IL; 2003 Aug.

39. Yang Y-X, Lewis JD, Epstein S et al. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006; 296:2947-53. [PubMed 17190895]

40. Eisai Inc. and Ortho-McNeil-Janssen Pharmaceuticals Inc. AcipHex (rabeprazole sodium) delayed-release tablets prescribing information. Woodcliff Lake and Raritan, NJ; 2009 Jan.

41. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (Nov 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

42. Bristol-Myers Squibb. Reyataz (atazanavir sulfate) capsules prescribing information. Princeton, NJ; 2009 Apr.

43. Gilard M, Arnaud B, Cornily JC et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin. JACC. 2008; 51:256-60, doi:10.1016/j.jacc.2007.06.064. Accessed 2008 Dec 8. Available from website. [PubMed 18206732]

44. Pezalla E, Day D, Pulliadath I. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. JACC. 2008; 52:1038-9. Letter. [PubMed 18786491]

45. MEDCO. New study: A common class of GI medications reduce protection against heart attack in patients taking widely prescribed cardiovascular drug. Franklin Lakes, NJ; 2008 Nov 11. Press release from website.

46. Gilard M, Cornily JC, Boschat J. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. JACC. 2008; 52:1039. Reply.

47. . PPI interactions with clopidogrel revisited. Med Lett Drugs Ther. 2009; 51:13-4.

48. Juurlink DN, Gomes T, Ko DT et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009; 180:713-8. [PubMed 19176635]

219. Gilard M, Arnaud B, Cornily JC et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin. JACC. 2008; 51:256-60, doi:10.1016/j.jacc.2007.06.064. Accessed 2008 Dec 8. Available from website. [PubMed 18206732]

220. Pezalla E, Day D, Pulliadath I. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. JACC. 2008; 52:1038-9. Letter. [PubMed 18786491]

221. MEDCO. New study: A common class of GI medications reduce protection against heart attack in patients taking widely prescribed cardiovascular drug. Franklin Lakes, NJ; 2008 Nov 11. Press release from website.

223. . PPI interactions with clopidogrel revisited. Med Lett Drugs Ther. 2009; 51:13-4.

224. Sanofi-Aventis/Bristol-Myers Squibb. Plavix, (clopidogrel bisulfate) tablets prescribing information. New York, NY; 2010 Mar.

225. Food and Drug Administration. Early communication about an ongoing safety review of clopidogrel bisulfate (marketed as Plavix). Rockville, MD; 2009 Jan 26. From FDA website.

226. Siller-Matula JM, Spiel AO, Lang IM et al. Effects of pantoprazole and esomeprazole on platelet inhibition by clopidogrel. Am Heart J. 2009; 157:148.e1-5.

227. Gilard M, Arnaud B, Le Gal G et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated to aspirin. J Thromb Haemost. 2006; 4:2508-9. [PubMed 16898956]

228. Anon. PPI interactions with clopidogrel. Med Lett Drugs Ther. 2009; 51:2-3.

229. Aubert RE, Epstein RS, Teagarden JR et al. Proton pump inhibitors effect on clopidogrel effectiveness: The clopidogrel Medco outcomes study. Circulation. 2008; 118:S_815, Abstract 3998.

230. Lau WC, Gurbel PA. The drug-drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009; 180:699-700. [PubMed 19332744]

232. Food and Drug Administration. Information for heathcare professionals: Update to the labeling of clopidogrel bisulfate (marketed as Plavix) to alert heathcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC). Rockville, MD; 2009 Nov 17. From FDA website.

233. Food and Drug Administration. Follow-up to the January 26, 2009 Early Communication about an ongoing safety review of clopidogrel bisulfate (marketed as Plavix) and omeprazole (marketed as Prilosec and Prilosec OTC). Rockville, MD; 2009 Nov 17. From FDA website.

234. Juurlink DN, Gomes T, Ko DT et al. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ. 2009; 180:713-8. [PubMed 19176635]

235. Ho PM, Maddox TM, Wang L et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009; 301:937-44.

236. Norgard NB, Mathews KD, Wall GC. Drug-drug interaction between clopidogrel and the proton pump inhibitors. Ann Pharmacother. 2009; 43:1266-74. [PubMed 19470853]

237. Last EJ, Sheehan AH. Review of recent evidence: potential interaction between clopidogrel and proton pump inhibitors. Am J Health Syst Pharm. 2009; 66:2117-22. [PubMed 19923312]

238. Stanek EJ, Aubert RE, Flockhart DA et al. A national study of the effect of individual proton pump inhibitors on cardiovascular outcomes in patients treated with clopidogrel following coronary stenting: the Clopidogrel Medco Outcomes Study. Available from website. Accessed 2009 Dec 15.

240. Stockl KM, Le L, Zakharyan A et al. Risk of rehospitalization for patients using clopidogrel with a proton pump inhibitor. Arch Intern Med. 2010; 170:704-10. [PubMed 20421557]

243. Juurlink DN. Proton pump inhibitors and clopidogrel: putting the interaction in perspective. Circulation. 2009; 120:2310-2. [PubMed 19933929]

248. Khalique SC, Cheng-Lai A. Drug interaction between clopidogrel and proton pump inhibitors. Cardiol Rev. 2009 Jul-Aug; 17:198-200. [PubMed 19525682]

250. Rude MK, Chey WD. Proton-pump inhibitors, clopidogrel, and cardiovascular adverse events: fact, fiction, or something in between?. Gastroenterology. 2009; 137:1168-71. [PubMed 19635603]

300. Vestergaard P, Rejnmark L, Mosekilde L. Proton pump inhibitors, histamine H2 receptor antagonists, and other antacid medications and the risk of fracture. Calcif Tissue Int. 2006; 79:76-83. [PubMed 16927047]

301. Corley DA, Kubo A, Zhao W et al. Proton pump inhibitors and histamine-2 receptor antagonists are associated with hip fractures among at-risk patients. Gastroenterology. 2010; 139:93-101. [PubMed 17190895]

302. Yu EW, Blackwell T, Ensrud KE et al. Acid-suppressive medications and risk of bone loss and fracture in older adults. Calcif Tissue Int. 2008; 83:251-9. [PubMed 19931262]

303. Gray SL, LaCroix AZ, Larson J et al. Proton pump inhibitor use, hip fracture, and change in bone mineral density in postmenopausal women: results from the Women's Health Initiative. Arch Intern Med. 2010; 170:765-71. [PubMed 20458083]

304. Targownik LE, Lix LM, Metge CJ et al. Use of proton pump inhibitors and risk of osteoporosis-related fractures. CMAJ. 2008; 179:319-26. [PubMed 18695179]

305. Food and Drug Administration. Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors. May 25, 2010. From FDA web site.

307. Yang YX, Metz DC. Safety of proton pump inhibitor exposure. Gastroenterology. 2010; :. [PubMed 20727892]

308. Targownik LE, Lix LM, Leung S et al. Proton-pump inhibitor use is not associated with osteoporosis or accelerated bone mineral density loss. Gastroenterology. 2010; 138:896-904. [PubMed 19931262]

309. Eisai Inc. and Ortho-McNeil-Janssen Pharmaceuticals. AcipHex (rabeprazole sodium) delayed-release tablets prescribing information. Woodcliff Lake and Raritan NJ; 2010 Aug.

310. Kaye JA, Jick H. Proton pump inhibitor use and risk of hip fractures in patients without major risk factors. Pharmacotherapy. 2008; 28:951-9. [PubMed 18657011]

311. Abraham NS, Hlatky MA, Antman EM et al. ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines: A Focused Update of the ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use. A report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. JACC. 2010; 56: Published online Nov 8, 2010.

More AcipHex resources

• AcipHex Side Effects (in more detail)
• AcipHex Dosage
• AcipHex Use in Pregnancy & Breastfeeding
• Drug Images
• AcipHex Drug Interactions
• AcipHex Support Group
• 29 Reviews for AcipHex - Add your own review/rating

• Aciphex Prescribing Information (FDA)


• Aciphex Advanced Consumer (Micromedex) - Includes Dosage Information


• Aciphex MedFacts Consumer Leaflet (Wolters Kluwer)


• Aciphex Consumer Overview

Compare AcipHex with other medications

• Barrett's Esophagus
• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• Erosive Esophagitis
• GERD
• Helicobacter Pylori Infection
• Stomach Ulcer
• Zollinger-Ellison Syndrome

Medi-Lyte

Pronunciation: e-LECK-troe-lite
Generic Name: Electrolyte
Brand Name: Examples include Medi-Lyte and Temp Tabs

Medi-Lyte is used for:

Decreasing fatigue, muscle cramps, or heat exhaustion due to excessive sweating. The use of Medi-Lyte for these conditions has not been evaluated or approved by the Food and Drug Administration. It may also be used for other conditions as determined by your doctor.

Medi-Lyte is an electrolyte combination. It works by replacing electrolytes in the body.

Do NOT use Medi-Lyte if:

• you are allergic to any ingredient in Medi-Lyte


• you have high blood potassium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Medi-Lyte:

Some medical conditions may interact with Medi-Lyte. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart disease, high blood pressure, fluid retention (eg, swelling of the hands, ankles, or feet), intestinal holes or punctures, difficulty urinating, kidney problems, or unexplained rectal bleeding


• if you have severe or persistent vomiting or severe diarrhea, or you are dehydrated


• if you have high levels of sodium in the blood


• if you are unable to properly absorb glucose from food

Some MEDICINES MAY INTERACT with Medi-Lyte. However, no specific interactions with Medi-Lyte are known at this time.

Ask your health care provider if Medi-Lyte may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Medi-Lyte:

Use Medi-Lyte as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Medi-Lyte with a full glass of water (8 oz/240 mL).


• If you miss a dose of Medi-Lyte, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Medi-Lyte.

Important safety information:

• If vomiting, fever, or stomach pain or bloating occurs, or if you have diarrhea that continues for longer than 24 hours, check with your doctor.


• Medi-Lyte should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Medi-Lyte while you are pregnant. It is not known if Medi-Lyte is found in breast milk. If you are or will be breast-feeding while you use Medi-Lyte, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Medi-Lyte:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Medi-Lyte side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Medi-Lyte:

Store Medi-Lyte at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Medi-Lyte out of the reach of children and away from pets.

General information:

• If you have any questions about Medi-Lyte, please talk with your doctor, pharmacist, or other health care provider.


• Medi-Lyte is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Medi-Lyte. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Medi-Lyte resources

• Medi-Lyte Side Effects (in more detail)
• Medi-Lyte Support Group
• 0 Reviews · Be the first to review/rate this drug

Loestrin Fe 1.5/30

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Loestrin Fe 1.5/30 resources

• Loestrin Fe 1.5/30 Side Effects (in more detail)
• Loestrin Fe 1.5/30 Use in Pregnancy & Breastfeeding
• Loestrin Fe 1.5/30 Drug Interactions
• Loestrin Fe 1.5/30 Support Group
• 0 Reviews for Loestrin Fe.5/30 - Add your own review/rating

• Aranelle Prescribing Information (FDA)


• Balziva Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Loestrin Fe 1.5/30 with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms
• Prevention of Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Loestrin Fe.5/30 side effects (in more detail)

Isonefrine

Isonefrine may be available in the countries listed below.

Ingredient matches for Isonefrine

Phenylephrine

Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Isonefrine in the following countries:

• Italy

International Drug Name Search